Siemens IMMULITE Thyroid Test Kit Recalled for Falsely Low Results
Siemens is recalling IMMULITE 2000 and XPi Thyroid Stimulating Immunoglobulins test kits due to a -23% negative bias that may produce falsely low results, potentially delaying diagnosis of autoimmune thyroid disease.
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: This is a Class II medical device presenting a risk-of-harm (potential for delayed diagnosis due to inaccurate test results) with no reported illnesses or injuries, meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) test kits, lot 389, expiration date November 30, 2022. The recall affects 100 units distributed in the United States to Florida, Indiana, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Ohio, Texas, and Utah. An additional 328 units were distributed outside the United States to Australia, Austria, Brazil, Czech Republic, Germany, Italy, China, Singapore, Spain, Taiwan, Tunisia, and Turkey.
The recalled kits exhibit an average negative bias of -23% compared to other in-date kit lots. This negative bias may cause test results to be erroneously depressed (lower than actual values).
Erroneously depressed results may lead to delayed follow-up of patients with clinical autoimmune thyroid disease.
The recalled product
- Product
- IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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 (2)
- UDI-DI: (01)00630414597188(10)D389S(17)221130 (US)
- (01)00630414597171(10)389(17)221130 (OUS) Lot Number: 389 Exp.Date: 2022-11-30
Distribution
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