Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
Reported: February 14, 2024 Initiated: November 21, 2023 #Z-0981-2024
Product Description
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
Reason for Recall
There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive Insulin APF applies an incorrect conversion factor when converting from system default units of ¿IU/mL to the International System of Units (SI units) of pmol/L.
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 19,125 reagent packs
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Croatia, Czech Republic, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410. Recalled by Beckman Coulter, Inc.. Units affected: 19,125 reagent packs.
Why was this product recalled? ▼
There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive Insulin APF applies an incorrect conversion factor when converting from system default units of ¿IU/mL to the International System of Units (SI units) of pmol/L.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2024. Severity: Moderate. Recall number: Z-0981-2024.
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