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U.S. Department of Health and Human Services

Class 2 Device Recall Strep A Twist Rapid Test Cassette

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  Class 2 Device Recall Strep A Twist Rapid Test Cassette see related information
Date Initiated by Firm September 01, 2011
Date Posted February 22, 2012
Recall Status1 Terminated 3 on June 28, 2012
Recall Number Z-1075-2012
Recall Event ID 60959
510(K)Number K023766  
Product Classification Antigens, all groups, streptococcus spp. - Product Code GTY
Product Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes.

Brand Name (Catalog Number): ACON Rapid Device Strep A Twist (IST-502T); CONSULT Diagnostics Strep A Twist, PSS (5005); Medi-Lab Performance Strep A Test-Twist, McKesson (32-502T); MooreBrand Strep A Twist Cassette, Moore (82793); and SP Strep A Rapid Twist Cassette Test, Cardinal Health (B1077-29).

Type of Packaging (ie. box, plastic bag): Individually pouched devices (number of tests per kit varies from 5 to 50), the kits also include: disposable extraction test tubes, dropper tips, sterile swabs, 1 vial Strep A reagent A (10 mL): 2M Sodium Nitrite, 1 vial Strep A reagent B (10 mL): 0.4M Acetic Acid, 1 vial Strep A positive control (1 mL): Nonviable Strep A; 0.09% NaN3, 1 vial Strep A negative control (1 mL): Nonviable Strep C; 0.09% NaN3 in a labeled kit box.

The Strep A Rapid Test Cassette and Twist devices are qualitative, lateral flow immunoassays for the detection of Strep A carbohydrate antigen in a throat swab, providing results within 5 minutes. The tests utilize antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen. The Cassette device uses a drop-wise application method while the Twist device has an onboard well to extract the throat swab specimen. The Strep A Rapid Test Devices are rapid chromatographic immunoassays for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.
Code Information All lots of Twist Devices product manufactured since August 2009.
Recalling Firm/
Manufacturer		 Alere San Diego
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact
858-455-4808 Ext. 3015
Manufacturer Reason
for Recall		 Alere San Diego is expanding the scope of the voluntary recall of the Strep A Rapid Test Cassette and Twist devices from the single lot that was recalled in January 12, 2011 to all lots of product that were on the market within the expiry period.
FDA Determined
Cause 2		 Process change control
Action The firm, Alere, sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 1, 2011 to its customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to retain the recall letter for their records as documentation that they have received the recall information. Customers were instructed to follow the directions and return the attached Verification Form. Customers were instructed to use the table in the Verification Form to document all inventory at any of their inventory locations. Customers may use multiple forms to document all sites, products, and lots. Alere will issue credit against PO#ASD811STA for any unused portion of the product based on completion and return of the attached Verification Form. Customers with any technical questions about the information contained in the notification were instructed to contact Alere by phone (877) 866-5309, fax (877) 866-9304 or email: ca2services@Alere.com.
Quantity in Commerce 2,797,600 devices (228 lots)
Distribution Worldwide distribution: USA (nationwide) and countries of : Austria, Canada, Cyprus, Denmark, Finland, Germany, Greece, Hungary, Iceland, Italy, Poland, Portugal, Romania, Slovenia, Spain, Switzerland, and United Kingdom.
Total Product Life Cycle 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 = GTY and Original Applicant = ACON LABORATORIES CO.
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