Attest Auto Reader 290 User Manual

Posted : admin On 10/7/2021

Product/Service

The Attest 190 auto-reader provides appropriate incubation temperature and quick, accurate fluorescent readout of Attest 1292E rapid readout biological indicators. The reader is color-coded with brown to match the Attest 1292E biological indicator cap color. The system is. After processing, the biological indicator is activated and incubated in the 3M™ Attest™ Auto-reader. A final negative reading after the specified incubation period indicates an acceptable sterilization process. A 24-minute result is provided when incubated in Model 490 or 490H Auto-readers having software version 4.2.7 or greater. The 3M™ Attest™ Auto-reader 290G are designed to incubate the 3M™ Attest™ 1294-S at 37ºC ± 2ºC and automatically read the fluorescent response of the 3M™ Attest™ 1294-S with a final end point reading at 4 hours. (or a time validated by the end user) to look for a media colour change. The 3M™ Attest™ Auto-reader 290.

Source: 3M Life Sciences

3M offers a series of Attest™ Biological Indicators used for validation and routine sterilization monitoring in ethylene oxide (EO) or moist heat processes. These indicators are convenient, compliant, and efficient sterility assurance monitors available in standard 24-48 hour readout, and rapid 1-4 hour readout modes.

Attest 390 auto reader manual

Attest Auto Reader 290 Service Manual

The Attest biological indicators are made up of highly resistant, standardized populations of Bacillus atrophaeus for EO sterilization, or geobacillus stearothermophilus or Bacillus stearthermophilus for moist heat sterilization. Reduced incubation time with Attest biological indicator products can improve inventory levels and increase turns. The 3M™ Attest™ Auto-Reader 390 (Steam), 3M™ Attest™ Auto-Reader 390G (EO), and 3M™ Attest™ Biological Indicator Incubators are made available to provide the optimal conditions for accurate readouts of the Attest biological indicators.

Download the datasheet for more product features, indicator testing frequencies, instructions for use, suggested subculturing techniques, and more.

3m Attest 290 Service Manual

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3m Attest Auto Reader 390


Attest 390 Auto Reader Manual

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Class 2 Device Recall 3M AttestTM Autoreader
Date Initiated by FirmJune 09, 2014
Date PostedJuly 07, 2014
Recall Status1Terminated 3 on June 03, 2015
Z-2002-2014
Recall Event ID68415
Indicator, biological sterilization process - Product CodeFRC
Product3M 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.
Code InformationAll serial numbers.
Recalling Firm/
Manufacturer
3M Company - Health Care Business
3M Center 2510 Conway Ave , B# 275-5-W-6
Saint Paul MN 55144
For Additional Information Contact3M Health Care Helpline
800-228-3957
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.
Labeling Change Control
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.
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) Database510(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