- 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. To adhere the label to a portion of the plastic covering each unit in a location where it is visible to the end-user. After that, they are requested to fill.
- 3M Attest Rapid Readout Biological Indicator For Steam is a dual readout biological indicator system specifically designed for rapid and reliable monitoring for 121-123°C Gravity and 132-135°C Vacuum-Assisted steam sterilization processes when used in conjunction with the 3M Attest Auto-reader 290 or the 3M Attest Auto-reader 390.
Catalogue Number: 3M490 The 3M™ Attest™ Auto‑reader 490 is designed to incubate and automatically read 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 at 56°C for a final negative fluorescence reading at 30 minutes and 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V at 56°C for a final negative fluorescence reading at 1 hour.
Attest Auto Reader 290 Service Manual
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Consignees were sent on 6/9/2014 a 3M 'Urgent Medical Devices Correction' letter dated May 21, 2014. The letter described the problem and the product involved in the recall. The letter described what action is 3M taking and what action was required of the consignees. Consignees were sent an adhesive label and a response card. They requested consignees to adhere the label to a portion of the plastic covering each unit in a location where it is visible to the end-user. After that, they are requested to fill out and return the response card. | |||||||||||||||||||||||||||
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5343 (2621 USA, 2722 OUS) | |||||||||||||||||||||||||||
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRALIA, CANADA, CHILE , COLOMBIA, COSTA RICA, SOUTH AFRICA, BRAZIL, GERMANY, ECUADOR, DUBAI, JAPAN, HONG KONG , CHINA, KOREA, MALAYSIA, PANAMA, SINGAPORE, VATICAN, and THAILAND. | |||||||||||||||||||||||||||
TPLC Device Report | |||||||||||||||||||||||||||
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55. | |||||||||||||||||||||||||||
510(K) Database | 510(K)s with Product Code = FRC and Original Applicant = 3M COMPANY 510(K)s with Product Code = FRC and Original Applicant = 3M COMPANY-3M HEALTH CARE |