Retiro De Equipo (Recall) de Device Recall SP Brand Strep A Cassette

Recall

57715

Class 2

Z-1395-2011

2011-01-12

2011-02-22

Terminated

United States

2012-06-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97073

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.

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 attechservices@alere.com.