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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
See all 27 products in this recall →Related recalls
Same manufacturer · GOLD STAR DISTRIBUTION INC
See all →- HighToothbrushes recalled over rodent activity in a distribution center
FDA (Devices) · 2026-02-04
- ModeratePacemaker and venous access packs recalled over cracking adhesive tubing
FDA (Devices) · 2026-02-04
- HighCondoms recalled over rodent activity in a distribution center
FDA (Devices) · 2026-02-04
- HighPregnancy tests recalled over rodent activity in a distribution center
FDA (Devices) · 2026-02-04
- HighFeminine hygiene products recalled over rodent activity in a distribution center
FDA (Devices) · 2026-02-04
Same hazard · false negative
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighHologic Aptima HPV assay may produce invalid or false negative results
FDA (Devices) · 2026-03-25
- HighC. difficile assay recalled over declining performance and false negative results
FDA (Devices) · 2026-01-14
Similar recalls
- ModerateFibrinogen test kits recalled over potential cross-contamination in heparin assays
FDA (Devices) · 2025-09-03
- HighFDA Recalls DiaSorin HSV-2 Antibody Test Lots Due to False Positive Results
FDA (Devices) · 2024-01-31
- ModerateAnti-Xa test kits recalled over potential contamination by fibrinogen reagents
FDA (Devices) · 2025-09-03
- ModerateSiemens ADVIA Centaur aTG Test Kits Recalled for Positive Bias
FDA (Devices) · 2019-05-08
- ModerateHyphen BioMed Recalls ZYMUTEST HIA IgGAM Assay Kits Due to Incorrect Package Insert
FDA (Devices) · 2018-05-16
- ModerateAnti-Xa 4 test kits recalled over potential fibrinogen reagent contamination
FDA (Devices) · 2025-09-03