Abbott ARCHITECT STAT myoglobin calibrators recalled for calibration failure
Abbott is recalling 402 kits of ARCHITECT STAT myoglobin calibrator that failed stability testing and may produce out-of-specification calibration results. The affected calibrators could impact the accuracy of myoglobin measurements used in clinical diagnostics.
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: This is a Class II medical device recall with no reported illnesses or injuries. The hazard is a quality/performance issue where the calibrator lot failed stability testing and may produce out-of-specification results, representing a risk to patient care through potentially inaccurate diagnostic measurements.
Plain-English summary
Abbott Laboratories is recalling 402 kits of ARCHITECT STAT Myoglobin Calibrators (RES 2K43-01). These calibrators are used to calibrate the ARCHITECT iSystem for quantitative myoglobin testing in human serum and plasma.
The recalled lot did not meet acceptance criteria during stability testing. When used for calibration, these calibrators may cause control values to exceed the specified ranges listed in the product's Instructions for Use (IFU).
The affected calibrators were distributed worldwide, including throughout the United States and to Austria, Belgium, Bosnia and Herzegovina, Croatia, Cyprus, Czech Republic, Denmark, France, Germany, Greece, Iraq, Italy, Kazakhstan, Lithuania, Luxembourg, Macedonia, Morocco, Panama, Portugal, Qatar, Romania, Saudi Arabia, South Africa, Sweden, Switzerland, and Turkey.
Healthcare facilities and laboratories using this product should discontinue use of the affected calibrators and contact Abbott Laboratories for instructions on obtaining replacement product. The product UDI code is (01)00380740003272(17)220531(10)166000.
The recalled product
- Product
- ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.
- Manufacturer
- Abbott Laboratories
- Affected units
- 402
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)
- UDI: (01)00380740003272(17)220531(10)166000
Distribution
Distributed nationwide across the United States.
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