Estrone RIA kits give falsely increased results from a bovine albumin lot
Estrone RIA kits are being recalled because a specific lot of bovine serum albumin used to manufacture the coated tubes caused falsely increased assay results. 496 units are affected.
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: Risk-of-harm product: the manufacturer states the kits produce falsely increased patient results, with no patient harm reported in the source.
Plain-English summary
Estrone RIA, REF DSL8700, an in vitro diagnostic used for the quantitative measurement of estrone in human serum and plasma, UDI 15099590211615, is being recalled. The action covers 496 units across lots 250106D, 250203C, 250203D, 250303C, 250331C, 250428C and 250526C.
According to the manufacturer, a specific lot of bovine serum albumin used in manufacturing the coated tubes included in the affected kit lots caused a different affinity of the manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted kits. The FDA classified the action as Class II. The source does not report any patient harm having occurred.
Distribution was to North Carolina in the United States and internationally to Argentina, Austria, Belgium, Canada, France and Germany among other countries.
Laboratories should identify affected stock using the REF, UDI and lot numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 496
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 (7)
- UDI: 15099590211615/Lot: 250106D
- 250203C
- 250203D
- 250303C
- 250331C
- 250428C
- 250526C
Distribution
Distributed in 1 state:
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