Stago free protein S assay may underestimate normal range results
Diagnostica Stago is recalling four lots of the STA Liatest Free Protein S kit because of the potential for out-of-range results and underestimation of free protein S in normal patient plasmas.
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 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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the assay may under-report a coagulation marker used in patient assessment, and no injuries are stated in the source.
Plain-English summary
Diagnostica Stago, Inc. is recalling the STA Liatest Free Protein S kit, catalogue number 00516, used on STA-R and STA Compact analysers for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. About 369 units were distributed across 23 US states and more than fifty other countries. The FDA has classified this recall as Class II.
There is the potential for out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
Affected product covers lot numbers 271971, 272859, 273018 and 273426.
Laboratories can identify affected kits by the catalogue number and lot numbers above, and may contact Diagnostica Stago, Inc. for further information.
The recalled product
- Product
- Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein…
- Manufacturer
- Diagnostica Stago, Inc.
- Affected units
- 369
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 (10)
- Model/Catalog Number (REF): 00516
- UDI: (1) (01)03607450005165(11)241001(17)260131(10)271971(241)00516
- (2) (01)03607450005165(11)250221(17)260531(10)272859(241)00516
- (3) (01)03607450005165(11)250306(17)260630(10)273018(241)00516
- (4) (01)03607450005165(11)250430(17)260831(10)273426(241)00516
- Lot numbers: (1) 271 971
- (2) 272 859
- (3) 273 018
- (4) 273 426
- Lot Code: 271 971 (01)03607450005165(11)241001(17)260131(10)271971(241)00516
Distribution
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