Medical Device Etching Solution Recalled for Potential Temperature-Related Effectiveness Loss
ABX Pentra Etching CP solution is recalled due to temperature excursions from June-August 2021 that may have affected product effectiveness. Affected lots were distributed June 1 - September 30, 2021.
What this means for you
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 medical device component where there is a potential risk of harm from temperature exposure that may have compromised product effectiveness. Although no illnesses or injuries have been reported, the theoretical hazard to medical diagnostics qualifies this as a risk-of-harm product per the rubric criterion for High severity.
Plain-English summary
The HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid (Product Reference: 1220001769) is being recalled. This is a 25 mL solution component used with the ABX Pentra 400 Clinical Chemistry Analyzer.
The manufacturer identified facility temperature excursions occurring from June 2021 through August 2021 prior to product delivery. These temperature conditions may have impacted the product's effectiveness.
All lots received between June 1, 2021 and September 30, 2021 are affected by this recall. The product was distributed nationally with GTIN 03610230005514.
The recalled product
- Product
- HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref: 1220001769
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
- effectiveness-loss
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 (1)
- GTIN: 03610230005514 Lots Distributed:5/30/2021 - 6/9/2021
Distribution
Distributed nationwide across the United States.
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