Heparin antibody test kits recalled over a defect producing negative results
Diagnostica Stago is recalling 438 Asserachrom HPIA kits from one lot because a potential defect can affect every well in an impacted strip and produce negative results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the defect can produce negative results on a diagnostic test, and no injuries are reported.
Plain-English summary
The Asserachrom HPIA kit, catalog number 00615, is being recalled by Diagnostica Stago, Inc. The record describes the kit as intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 antibodies generated during type II heparin-induced thrombocytopenia.
The reason given in the enforcement record is a potential defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
The record lists 438 units, reference number 00615, UDI (01)03607450006155, from lot 271288. Distribution was worldwide, including nationwide in the United States across Alabama, California, Florida, Georgia, Hawaii, Iowa, Massachusetts, Michigan, New Jersey, Nevada, New York, Ohio, Tennessee and Wisconsin. The FDA has classified the action as Class II.
A test that returns a negative result because of a defect can leave the condition it screens for undetected. The enforcement record reports no injuries. Laboratories should quarantine the affected lot and follow the firm's instructions.
The recalled product
- Product
- LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989
- Manufacturer
- GOLD STAR DISTRIBUTION INC
- Category
- Medical Device — Diagnostic test
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry distributed by Gold Star Distribution.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 27 recalled by GOLD STAR DISTRIBUTION INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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