The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.
FDA Recall Z-0805-2025 · Posted 2025-01-03
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Recalling FirmQualigen Inc
Recall StatusOpen, Classified
Product CodeCDZ
Date Initiated2024-12-03
Product Quantity426
Reason for Recall
Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due to age.
Firm Action
The recalling firm issued letters dated 11/19/2024 via email to their customers explaining the reason for recall and providing the correct expiration dates for each of the affected lot numbers. The risk to health was provided and instructions given to be completed. The instructions were to cease use of the affected product, dispose of all remaining kits from the affected lot numbers, document the number of kits disposed, complete the acknowledgment form by FAX or email within 5 days.
Root Cause
Labeling Change Control
Distribution Pattern
Distribution was made to AR, CA, CO, FL, IL, IN, MA, MO, NC, NY, OH, OK, TN, TX, and VA. There was no military/government/foreign distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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