| New Search | Back to Search Results |
| | Class 2 Device Recall 3M AttestTM Autoreader |
| Date Initiated by Firm | June 09, 2014 |
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| Date Posted | July 07, 2014 |
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| Recall Status1 | Terminated 3 on June 03, 2015 |
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| Z-2002-2014 |
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| | Recall Event ID | 68415 |
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Indicator, biological sterilization process - Product CodeFRC
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| | Product | 3M Attest Auto-reader. Model numbers 390, 390G,and 490.
These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
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| Code Information | All serial numbers. |
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Recalling Firm/
Manufacturer | 3M Company - Health Care Business
3M Center 2510 Conway Ave , B# 275-5-W-6
Saint Paul MN 55144
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| For Additional Information Contact | 3M Health Care Helpline
800-228-3957 |
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| Labeling on units shipped prior to May 16th, 2014 did not contain the statement 'This product contains dry natural rubber' as required by the United States Food and Drug Administration (FDA) for medical devices. The non-slip pads at the bottom of the unit contain dry natural rubber. One incident of an allergic reaction in a sensitized individual has been reported. |
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| | Labeling Change Control |
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Page 1: 3M 290
3 M ™ Attest ™ 290 Auto -reader Operator ’ s Manual Read and understand all s afety information before usin g this product.[..]
Page 2: 3M 290
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Page 3: 3M 290
3M © 2003 78-8 078-8977-5 Page 1 of 9 Attest 29 0 Auto-reader INTENDED USE 1. Cover 2. Incubation/Reader Wells 3. Crusher Well 4. Red Light Pos itive (+) Ind icator 5. Yello w Light ( •) Test In P r o gress Ind icat o r 6. Green Light Negative (-) Indicator 7. Buzzer Alarm OFF Button 8. Digital Dis play Panel 9. Time Re m aining Button Intended [..]
Manuals are usually written by a technical writer, but in a language understandable to all users of Allen & Heath ZED428.A complete Allen & Heath manual, should contain several basic components. A complete manual for the device Allen & Heath ZED428, how should it look like?A manual, also referred to as a user manual, or simply 'instructions' is a technical document designed to assist in the use Allen & Heath ZED428 by users. Allen heath zed 10 user manual. Some of them are less important, such as: cover / title page or copyright page.
Page 4: 3M 290
3M © 2003 78-8 078-8977-5 Page 2 of 9 Attest 290 A uto-reader SAFETY INFORMATION Explan ation of sym bols: Caution – Risk of electric shock Attention – Refer t o accompanying documents WARNING WARNING WARNING WARNING • To avoid the r isk of ele ctric sh ock, which if n ot avoided co uld result i n serious inj ury or death: - Do not immer se [..]
Page 5: 3M 290
3M © 2003 78-8 078-8977-5 Page 3 of 9 Attest 29 0 Auto-reader SAFETY INFORMATION Power Supply Specifications Power supply Operating Co ndition Units Voltag e Range 100-240 Volts A C Frequen cy 50/60 Hertz Current 1.2 Amps Environm ental Operating Condi tions Environme nt a l Co ndition Operating Co ndition Units Alti tude 2500 (max ) mete rs Opera[..]
Page 6: 3M 290
3M © 2003 78-8 078-8977-5 Page 4 of 9 Attest 290 A uto-reader INSTRUCTIONS FOR USE Operating Instructions Start- up Place unit on a firm level surface. Plug unit into an appropriate AC grounded outlet. All o w a 30 minute warm-u p period before pl acing RRBIs i nto the i ncubatio n well s. T he C1 caution code w ill disappear when proper incubatio[..]
Page 7: 3M 290
3M © 2003 78-8 078-8977-5 Page 5 of 9 Attest 29 0 Auto-reader INSTRUCTIONS FOR USE Wells are color coded to match the cap of each type of bio logical indicato r ; i.e. the 1291 RRBI with a blue cap g oes into a blue well and the 1292 RRBI w ith a brown cap goes into a brow n well. A yellow light will co me on to indicate the RRB I is incubatin g i[..]
Page 8: 3M 290
3M © 2003 78-8 078-8977-5 Page 6 of 9 Attest 290 A uto-reader INSTRUCTIONS FOR USE Positive Control Crush, tap and incubat e at least one n on-processed Attest 1291 or 1292 R RBI to use as the posit ive control each day that a processed RRBI is incu bated and read by the unit. Write a “C” (for “control”) an d the date on the label. T he po[..]
Page 9: 3M 290
3M © 2003 78-8 078-8977-5 Page 7 of 9 Attest 29 0 Auto-reader FEATURES, CARE AND CLEANIN G Features Audible Alar m An audible alar m will sound a nd the po siti ve red (+) light will illumina te for the d esignated incubatio n/reader well when a po sitive result is detected. This pr o vides results in the least a mount of time witho ut the need to[..]
Page 10: 3M 290
3M © 2003 78-8 078-8977-5 Page 8 of 9 Attest 290 A uto-reader TROUBLES HOOTING G UIDE Troub le Shooting G uide In the even t of an error code, u nplug th e Attest 290 Auto- reader and plug it back in to in itiate the s elf- diagnos tic test. If error code r e-occurs, call for repair or replacem ent. The display panel will indicate malfunctions det[..]
Page 11: 3M 290
3M © 2003 78-8 078-8977-5 Page 9 of 9 Attest 29 0 Auto-reader TROUBLES HOOTING GUIDE Trouble Shoo ting Guide (Co ntinued) Code Proble m Solution Other Unwanted alarm sounds when Turn alarm off, ref er to features positive detected . Section. Other All three lights blink and buzzer sou nds. Replace RRBI in incubation/ r eader RRBI has be e n re mov[..]
Page 12: 3M 290
3M © 2003 78-8 078-8977-5 Page 10 of 9 Attest 290 A uto-reader 3M Health Care 3M Center Buil ding 275-4E- 01 St. Paul , MN 55144-1000 1-800- 228-3957 3M Health Care D-41460 Neus s, Germany Recycled paper 40% pre-con sumer 10% post- consumer Litho in U.S.A. with 3M film , proofin g system s and off set plates. Attest is a regis tered trademark of 3[..]
