Meridian Premier EHEC Diagnostic Kits Recalled for False Positive Results
Meridian Bioscience is recalling Premier EHEC and Premier EHEC Bulk diagnostic kits because internal testing showed they can produce false positive results with some broth specimens.
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: The FDA classified this as a Class II recall. While no injuries or illnesses are reported, the risk of false positive results in diagnostic testing represents a significant potential for harm or misdiagnosis, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Meridian Bioscience Inc is recalling specific lots of the PREMIER EHEC and PREMIER EHEC Bulk diagnostic kits. The recall involves 4,747 units of PREMIER EHEC and 180 units of PREMIER EHEC Bulk. The affected products were distributed to numerous U.S. states and several international countries, including Canada, Germany, Hong Kong, Italy, Japan, and New Zealand.
The recall was initiated because internal testing demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens. This issue could lead to inaccurate diagnostic outcomes for users of the kits.
The FDA has classified this recall as Class II. Users of the affected products should stop using the kits and contact Meridian Bioscience for further instructions or a refund.
The recalled product
- Product
- PREMIER EHEC and PREMIER EHEC Bulk.
- Manufacturer
- Meridian Bioscience 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 (20)
- PREMIER EHEC Product Code 608096: Lot # 608096H219
- Exp Date 9/7/2017
- Detection Antibody Reagent
- Lot # 8603.138 Exp Date 9/30/2017
- Lot # 608096H222
- Exp Date 12/20/2017
- Lot # 8603.14 Exp Date 1/12/2018
- Lot # 608096H224
- Lot # 8603.141 Exp Date 1/29/2018
- Lot # 608096H225
- Lot # 8603.142
- Exp Date 2/5/2018 & Lot # 608096H226
- Exp Date 3/6/2018
- Lot # 8603.143
- Lot # 8603.138
- Exp Date 9/30/2017
- Lot #
- 608096H223
- Lot # 8603.14
- Exp Date 1/12/2018 & Lot # 608096H227
Distribution
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