Siemens SHBG Immulite 2000 Reagent Recall Due to Stability Issues
Siemens is recalling certain lots of SHBG Immulite 2000 reagents because they may not meet stability claims, potentially causing test bias.
What this means for you
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, and the hazard involves potential test bias without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 9,100 kits of Sex Hormone Binding Globulin (SHBG) Immulite 2000/IMMULITE 2000 XPi reagents. The affected lots are 357, 358, 360, 361, and 363, with expiration dates ranging from January 30, 2017, to June 30, 2017. These products were distributed nationwide.
The recall was initiated because certain lots of the SHBG reagents do not meet the 30-day open vial adjustor stability claim when reconstituted and stored at 2-8°C, as stated in the Instructions for Use. If the adjustors are stored at 2-8°C for more than 14 days, they may show a bias in patient samples and quality control results may fall outside of published ranges.
The FDA has classified this as a Class II recall. The source text states that a lookback is not recommended. Users should discontinue use of the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 9,100
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)
- Lot Numbers: 1) 357
- 2) 358
- 3) 360
- 4) 361 & 5) 363 Expiration Dates: 1) 2017-01-30
- 2) 2017-03-31
- 3) 2017-04-30
- 4) 2017-05-31 & 5) 2017-06-30
Distribution
Distributed nationwide across the United States.
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