Quidel MicroVue Intact PTH EIA Recalled for Potential Calibration Issues
Diagnostic Hybrids, Inc. is recalling 26 units of the Quidel MicroVue Intact PTH EIA due to a potential loss of separation between calibrators that may impact assay calibration.
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 source text explicitly states the agency classification is Class III, which the rubric defines as typically resulting in a score of 1 or 2 because adverse health consequences are unlikely.
Plain-English summary
Diagnostic Hybrids, Inc. is recalling 26 units of the Quidel MicroVue Intact PTH EIA, Model 8044. This product is an enzyme immunoassay used for the quantification of Intact Parathyroid Hormone (PTH) in serum. The specific lot number is 068259.
The recall was initiated because there may be a loss of separation between Calibrators A and B. This issue may impact the assay calibration at the lower end of the assay. The product was distributed to Singapore and Switzerland.
The U.S. Food and Drug Administration has classified this recall as Class III. This classification indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
- Manufacturer
- Diagnostic Hybrids, Inc.
- Hazard
- Affected units
- 26
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)
- Lot 068259
Distribution
Distribution scope not specified by the agency.
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