QMS Tacrolimus Calibrators Recalled for Quality Degradation from Improper Storage
Ortho-Clinical Diagnostics is recalling QMS Tacrolimus Calibrators Lot 74859619 due to improper storage that degrades product quality, potentially causing erroneous test results and testing delays.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This Class II medical device recall has no reported illnesses or injuries. The hazard—erroneous calibration results from degraded product quality—is theoretical. Per the rubric, recalls without reported harm and with only theoretical hazards from quality issues qualify as Moderate (Score 2).
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators (Product code 10015573), Lot 74859619, expiry May 11, 2024, because improper storage has degraded the product quality. The affected calibrators are unsuitable for use.
If used despite degradation, the affected lot may produce erroneous calibration results, potentially causing delays in testing. The recalled calibrators were distributed domestically to facilities in Illinois, Indiana, Florida, New Jersey, New Mexico, and Texas, and internationally to Chile.
Any facility that has received this lot should stop using it. For more information or to report any issues, contact Ortho-Clinical Diagnostics, Inc.
The recalled product
- Product
- QMS Tacrolimus Calibrators, Product code 10015573
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
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)
- No UDI Lot 74859619
- Expiry 11-May-2024
Distribution
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