Capillary tubes recalled over a positive bias in potassium results
Medica Corporation is recalling 1,578 capillary tube kits after a systematic positive bias of up to 20% was identified across the reportable potassium range.
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: Scored 3 under the risk-of-harm criterion: the firm states the tubes produce falsely elevated potassium results in patient samples, and no injuries are reported.
Plain-English summary
Medica Capillary Tubes, EasyBloodGas/EasyStat Capillary Tube Kit, are being recalled by Medica Corporation.
The record states a systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica's capillary tubes.
The record lists 1,578 units under model number 7303, UDI-DI 00840095607575, lot number 25XXX. Distribution was international, to Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan and other countries listed in the enforcement record. The FDA has classified the action as Class II.
A falsely elevated potassium result can change how a patient is treated. The enforcement record reports no injuries. Laboratories should quarantine the affected lot and follow Medica's instructions.
The recalled product
- Product
- Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
- Manufacturer
- Medica Corporation
- Affected units
- 1,578
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 (3)
- Model No. 7303
- UDI-DI: 00840095607575
- Lot No. 25XXX.
Distribution
Distribution scope not specified by the agency.
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