Medtest Holdings Recalls CK-MB Control Kits Due to Labeling Error
Medtest Holdings is recalling five CK-MB Isoenzyme Control Kits because the product labeling contains an incorrect control range.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is limited to a labeling error.
Plain-English summary
Medtest Holdings, Inc. is recalling five units of the Pointe Scientific CK-MB Isoenzyme Control, Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit. The recall was initiated because the product labeling contains an incorrect control range.
The affected products are identified by Model C7562-12 Control Kit, Lot 013206-260, and an expiration date of 2013-03. The distribution pattern for these units includes Florida, Arkansas, Nicaragua, and Korea.
Consumers and healthcare facilities should stop using the affected control kits and contact Medtest Holdings, Inc. for further instructions or a refund.
The recalled product
- Product
- The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
- Manufacturer
- Medtest Holdings, Inc.
- Hazard
- Affected units
- 5
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)
- Model C7562-12 Control Kit. Lot: 013206-260
- Expiration Date: 2013-03
Distribution
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