Diagnostica Stago Recalls STA N¿oplastine¿ CI Reagents Due to Quality Control Issues
Diagnostica Stago is recalling STA N¿oplastine¿ CI in-vitro diagnostic kits because quality control values fell outside assigned ranges, potentially affecting prothrombin time test results.
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 quality control deviation in an in-vitro diagnostic, which fits the criteria for a moderate severity recall involving potential test inaccuracies without reported harm.
Plain-English summary
Diagnostica Stago, Inc. is recalling 5 kits of STA N¿oplastine¿ CI, 10 ml vials, which are in-vitro diagnostic reagents used to determine prothrombin time (PT) in plasma. The recall is due to quality control values falling outside of assigned ranges, specifically showing prolonged Prothrombin time and decreased PT %.
The affected lots are 251426 (expiration date 2018-11-30) and 251763 (expiration date 2019-02-28). The product was distributed nationwide. These kits are used with STA-R¿, STA Compact¿, and STA Satellite¿ analyzers.
Healthcare facilities and laboratories should stop using the affected lots and contact Diagnostica Stago, Inc. for instructions on return or replacement. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA¿ - N¿oplastine¿ CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA…
- Manufacturer
- Diagnostica Stago, Inc.
- Affected units
- 5
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)
- 251763 2019-02-28 (01)03607450006667(11)170228(17)190228(10)251763(241)00666
Distribution
Distributed nationwide across the United States.
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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