Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall SP Brand Strep A Cassette

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall SP Brand Strep A Cassette see related information
Date Initiated by Firm January 12, 2011
Date Posted February 22, 2011
Recall Status1 Terminated 3 on June 26, 2012
Recall Number Z-1395-2011
Recall Event ID 57715
510(K)Number K031784  
Product Classification Antigens, all groups, streptococcus spp. - Product Code GTY
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.
Code Information Lot #: STA0010037
Recalling Firm/
Manufacturer		 Biosite Inc Dba Innovacon Inc.
9975 Summers Ridge Rd
San Diego CA 92121
For Additional Information Contact
858-455-4808 Ext. 3015
Manufacturer 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 Determined
Cause 2		 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 attechservices@alere.com.
Quantity in Commerce 814 kits/24,420 devices
Distribution Nationwide distribution
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, INC.
-
-