Z-1395-2011

SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037 The SP Brand Strep A Rapid Test Device is...

Name: Z-1395-2011 SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037 The SP Brand Strep A Rapid Test Device is...
Creator: Biosite Inc Dba Innovacon Inc.
Published: 2011-01-12
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2011-01-12 / Terminated

FDA source

Biosite Inc Dba Innovacon Inc. began a recall of 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... on 2011-01-12. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1395-2011
Status: Terminated
Initiated: 2011-01-12
Posted: 2011-02-22
Terminated: 2012-06-26
Recalling firm: Alere San Diego, Inc.
Product: 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.
Product code: GTY Antigens, All Groups, Streptococcus Spp.
Reason for recall: 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
FDA 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 replacement of their remaining inventory of this lot (if applicable). The customers were ask to please return the form even if they have no remaining inventory or do not have any involved product in order to confirm receipt of this notification; and (4) to please ensure that all users of the device have received a copy of this Urgent Medical Device Recall. Customers with questions about the information contained in the notice were instructed to contact Technical Services at 888-246.7483, option 2 or by e-mail [email protected].
Quantity in commerce: 814 kits/24,420 devices
Distribution: Nationwide distribution
Product codes and lots: Lot #: STA0010037

Product code GTY

K031784Class IAcon Strep a Rapid Test DeviceACON Laboratories, Inc. / cleared 2003-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)