{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "35617", "product_res_number": "Z-0277-05", "event_date_initiated": "2004-10-06", "event_date_posted": "2004-12-03", "recall_status": "Terminated", "event_date_terminated": "2005-03-24", "res_event_number": "30288", "product_code": "LCX", "k_numbers": [ "K933529" ], "product_description": "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_info": "Lot U040904 (Exp. 30 SEP 06) ; Recall Expansion: lot U032904/1 (Exp. 30 AUG 06 - 14,364 units distributed)", "firm_fei_number": "2431980", "recalling_firm": "Chembio Diagnostic System Inc", "address_1": "3661 Horseblock Road", "city": "Medford", "state": "NY", "postal_code": "11763-2215", "additional_info_contact": "David W. Gates\n631-924-1135 Ext. 122", "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.", "root_cause_description": "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.", "product_quantity": "42,005 (total of 2 lots)", "distribution_pattern": "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.", "openfda": { "k_number": [ "K203246", "K050930", "K213379", "K772359", "K972682", "K941771", "K852274", "K984075", "K132085", "K131931", "K840602", "K941355", "K934830", "K031798", "K051963", "K050305", "K933794", "K921099", "K190705", "K103487", "K150022", "K032661", "K023638", "K240025", "K874248", "K914990", "K843238", "K831051", "K172627", "K882588", "K990373", "K200133", "K122907", "K861946", "K033658", "K200913", "K182328", "K041273", "K042280", "K193318", "K911566", "K974059", "K031271", "K192123", "K883826", "K234152", "K832593", "K230741", "K962888", "K860090", "K171136", "K841415", "K871996", "K050546", "K993483", "K880069", "K181551", "K183097", "K895560", "K053138", "K023126", "K123703", "K921012", "K060128", "K112449", "K954364", "K032510", "K974021", "K041404", "K904782", "K233174", "K062703", "K180771", "K070054", "K962521", "K896482", "K213808", "K243573", "K962183", "K150063", 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"medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1155", "device_class": "2" } } ] }