Diagnostica Stago Recalls STA Unicalibrator Due to Positive Bias
Diagnostica Stago is recalling 5,498 units of STA Unicalibrator because a positive bias was confirmed when compared to International Standards.
The agency’s classification
FDA (Devices): 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a measurement bias (positive bias) rather than a direct physical or biological threat, fitting the criteria for a moderate severity recall involving quality control issues without reported harm.
Plain-English summary
Diagnostica Stago, Inc. is recalling 5,498 units of the STA Unicalibrator (ref. 00675). The recall affects specific lot numbers: 253180, 253964, 254721, and 255108. The product was distributed in 36 U.S. states and the District of Columbia.
The recall was initiated because a positive bias was confirmed to exist on the STA Unicalibrator levels with STA Deficient IX and STA Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias was also observed on several External Quality Assessment (EQA) results.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take. The recall is classified as Class II by the FDA.
The recalled product
- Product
- STA UNICALIBRATOR (ref. 00675)
- Manufacturer
- Diagnostica Stago, Inc.
- Hazard
- Affected units
- 5,498
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 (3)
- REF: 00675 Lot Numbers: 253180
- 253964
- 254721
Distribution
Part of a larger recall action
This product is one of 2 recalled by Diagnostica Stago, Inc. under a single FDA (Devices) 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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