Recall Z-1395-2011 ยท GTY Antigens, All Groups, Streptococcus Spp.
Biosite Inc Dba Innovacon Inc.
SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037 The SP Brand Strep A Rapid Test Device is a rapid chromatographic immunoassay 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.
| Date | Feb 22, 2011 (initiated Jan 12, 2011) |
| Status | Terminated |
| Reason | The recall was initiated after the Investigation of customer-reported complaints, testing of market retention and returned product, It was determined that this lot of product has demonstrated an elevated Incidence of non-specific binding, potentially causing false positive results. A false positive test result could lead to the administration of antibiotics that are unnecessary. This exposes the |
| Root cause | Pending |
| Action | The firm, Alere San Diego, sent a "URGENT MEDICAL DEVICE RECALL" letter dated January 17, 2011. The letter described the product, problem and action to be taken by customers. The customers were instructed to: (1) Immediately discontinue use of the affected lot (if applicable) and inventory remaining full or partial kits at their site (if applicable); (2) Destroy any remaining inventory of this lot and document destruction per their site requirements (if applicable); (3) Complete and FAX the enclosed Verification Form within 10 days to confirm their receipt of this notice and to receive repla |
| Quantity | 814 kits/24,420 devices |
| Distribution | Nationwide distribution |
| 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 |