Insulin Assay Reagent Packs Recalled for Incorrect Unit Conversion
Beckman Coulter is recalling 19,125 Access Ultrasensitive Insulin reagent packs due to an incorrect unit conversion factor in the assay protocol file. The error could produce inaccurate insulin test results.
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: FDA Class II medical device recall involving a unit conversion error in an assay protocol file that could produce inaccurate test results. No illnesses or injuries have been reported, making this a theoretical risk of harm from incorrect laboratory results.
Plain-English summary
Beckman Coulter, Inc. is recalling Access Ultrasensitive Insulin reagent packs (Catalog Number 33410), which are used exclusively with the DxI 9000 Access Immunoassay Analyzer. The recall affects 19,125 reagent packs that were distributed worldwide, including throughout the United States and to 22 other countries: Australia, Austria, Belgium, Croatia, Czech Republic, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
The Access Ultrasensitive Insulin assay protocol file (APF 182 test definition version 6.7 and below) contains an error in its conversion factor. When converting insulin measurements from the analyzer's default units of IU/mL (International Units per milliliter) to SI units of pmol/L (picomoles per liter), the incorrect conversion factor produces inaccurate results.
Healthcare facilities and laboratories using the affected reagent packs may receive incorrect insulin test results. The affected lot numbers are: 125533, 125589, 233656, 233919, 234055, 234339, and 234388 (UDI/DI 15099590230623).
The recalled product
- Product
- Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 19,125
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 (8)
- UDI/DI 15099590230623
- Lot Numbers: 125533
- 125589
- 233656
- 233919
- 234055
- 234339
- 234388
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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