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U.S. Department of Health and Human Services

Class 2 Device Recall Sure Check hCG Cassette Pregnancy Test

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  Class 2 Device Recall Sure Check hCG Cassette Pregnancy Test see related information
Date Initiated by Firm October 06, 2004
Date Posted December 03, 2004
Recall Status1 Terminated 3 on March 24, 2005
Recall Number Z-0277-05
Recall Event ID 30288
510(K)Number K933529  
Product Classification Kit, Test, Pregnancy, Hcg, Over The Counter - Product Code LCX
Product OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti-¿ hCG monoclonal antibody conjugated to colloidal gold contained in a plastic cassette. It differs from the Sure Check Midstream product in that the lateral flow membrane pad is placed in a cassette and the urine sample is added by pipette rather than by urinating on the absorbent wick. The device is packaged in a foil pouch with desiccant. This product is shipped as bulk packaged product of varying quantities (Catalog # PT127-OTC ordered by Innovative Chemical Co., and Pruebas Moderna Del Istmo; Catalog # PT210 ordered by LABSCO). --- 510(k) K933529/A.
Code Information Lot U040904 (Exp. 30 SEP 06) ; Recall Expansion: lot U032904/1 (Exp. 30 AUG 06 - 14,364 units distributed)
Recalling Firm/
Manufacturer		 Chembio Diagnostic System Inc
3661 Horseblock Road
Medford NY 11763-2215
For Additional Information Contact David W. Gates
631-924-1135 Ext. 122
Manufacturer Reason
for Recall		 Poor sealing of pouches and degradation of products. Firm received an e-mail from a distributor of an increase in complaints. In response to the complaints, the distributor conducted its own functional testing and noticed a degradation in performance of the two lots. Chembio's investigation revealed invalid results (no control lines) and some false negatives.
FDA Determined
Cause 2		 Other
Action Recall letters on 10/6/04, followed by a second letter on/about 10/20/04. Recall letters mailed on 11/9/04 to cover recall expansion for 4 additional lots.
Quantity in Commerce 42,005 (total of 2 lots)
Distribution Distributors in KS, TN, NC, MA, NY, KY, FL, NV, and Puerto Rico for further distribution to their retail customers. Products also distributed to accounts in Barbados WI, Israel, Costa Rica and Canada.
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 = LCX and Original Applicant = VISTULA ASSISTANCE & CONSULTING BUREAU
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