Randox Clinical Chemistry Calibration Serum Recalled for Measurement Bias
Randox Laboratories has recalled Clinical Chemistry Calibration Serum (Cal2351/Cal10388) due to negative bias in inorganic phosphate measurements on RX Series instruments. The issue could affect the accuracy of clinical chemistry test results.
What this means for you
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 risk-of-harm product where calibration errors could lead to inaccurate clinical test results and potential misdiagnosis. The negative bias in inorganic phosphate measurement could affect diagnostic accuracy across 38 clinical chemistry tests. No illnesses or injuries have been reported, meeting the High category criterion for risk-of-harm products without reported injury.
Plain-English summary
Randox Laboratories Ltd. has recalled Clinical Chemistry Calibration Serum with catalog numbers Cal2351 and Cal10388. The serum is a lyophilized human-based calibration reagent used to verify the accuracy of laboratory instruments, covering 38 commonly used clinical chemistry tests. The recall affects 80,366 units worldwide, including 242 units distributed in the United States.
The company identified that inorganic phosphate in Calibration Serum Level 3 is running with a negative bias on RX Series instruments when compared to other testing methods. This negative bias could affect the accuracy of clinical chemistry test results across the 38 tests covered by this calibration serum. Affected lot numbers include 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, and 1326UE.
Laboratories using affected lots should discontinue use for calibration and verification purposes. Affected facilities should contact Randox Laboratories Ltd. for instructions on obtaining replacement calibration serum. No illnesses or injuries associated with this recall have been reported to date.
The recalled product
- Product
- Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- analytical-bias
- test-inaccuracy
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 (11)
- Catalogue No. CAL2351 & CAL10388
- GTIN: 05055273200966
- Lot No. 1260UE
- 1262UE
- 1295UE
- 1297UE
- 1298UE
- 1315UE
- 1325UE
- 1326UE
- & 1325UE.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27