Reported Jan 15, 2025 · Ongoing
The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG…
Qualigen Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qualigen Inc · 2042 Corte Del Nogal · Carlsbad, CA · 92011-1438
Is this the product you have?
- 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.
- Lot codes and dates
- UDI-DI20816467020345
- Lot numbers2408018-1
- Exp
2025-09-052409015-1
- Exp
2025-06-27and 2409015-2
- Exp2025-06-26
- Amount recalled
- 426
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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