Recall Z-1074-2012 ยท GTY Antigens, All Groups, Streptococcus Spp.
Alere San Diego
Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog Number): Acceava Strep A Cassette (92004 E-Z); Accutest Integrated Strep A Rapid Test Device JANT (ID440); ACON Strep A Rapid Test Device (IST-502); BD Directigen EZ Group A Strep, Becton Dickinson (256032); Clearview Strep A Exact II Cassette (920003), CONSULT Diagnostics Strep A Cassette, 25T, PSS (5004); CONSULT Di
| Date | Feb 22, 2012 (initiated Sep 1, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 mult |
| Quantity | 1,859,430 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031784 | ACON STREP A RAPID TEST DEVICE ACON Laboratories, Inc., Jul 14, 2003 |