Vital Scientific V-Twin Automated Chemistry Analyzer Recall for Cooling Defect
Vital Scientific N.V. is recalling 192 V-Twin automated chemistry analyzers because an improperly installed cooling indicator board may prevent warning signals if reagent cooling fails.
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: The recall involves a risk-of-harm product where the failure of a safety warning system could lead to compromised reagent conditions, but no injuries or illnesses have been reported.
Plain-English summary
Vital Scientific N.V. is recalling 192 units of the V-Twin automated chemistry analyzer (Catalog # 6002-800, UDI: 03661540600180). These in vitro diagnostic devices are intended for clinical use to measure various analytes, including applications in clinical chemistry, drug of abuse monitoring, and therapeutic drug monitoring. The affected units were distributed nationwide in the United States, including New York, and are identified by specific serial number ranges provided in the recall notice.
The recall was initiated because the cooling indicator board was improperly installed. This defect was first identified by a service employee during assembly. If the cooling of the reagent rotor fails, the reagent cooling indicator light will not illuminate, and the acoustic beeper will not activate. Consequently, the operator will not receive a warning, and the reagent storage conditions may fall out of specification, potentially compromising the integrity of the reagents.
The recalled product
- Product
- V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinic
- Manufacturer
- Vital Scientific N.V.
- Affected units
- 192
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 (5)
- The following serial numbers: 14-3301-14-3344
- 15-3301-15-3326
- 16-3301 -16-3353
- 17-3301 -17-3346
- 18-3301-18-3323
Distribution
Related recalls
Same manufacturer · Vital Scientific N.V.
See all →- HighV-Twin In Vitro Diagnostic Instruments Recalled for Sample Mismatch Risk
FDA (Devices) · 2019-12-04
- ModerateVital Scientific Viva-JR Automated Chemistry Analyzer Recalled for Power Supply Failure
FDA (Devices) · 2019-10-23
- HighVital Scientific Selectra ProM Analyzer Recalled for Power Supply Failure
FDA (Devices) · 2019-10-23
- ModerateVital Scientific Selectra ProS Analyzer Recalled for Power Supply Failure
FDA (Devices) · 2019-10-23
- ModerateVital Scientific Viva-E Automated Chemistry Analyzer Recalled for Power Supply Failure
FDA (Devices) · 2019-10-23
Same hazard · cooling failure
See all →- HighArtis Q floor X-ray system cooling failure poses overheating risk
FDA (Devices) · 2022-04-27
- ModerateX-Ray Imaging System Cooling Circuit Failure Recall
FDA (Devices) · 2022-04-27
- HighSiemens Artis Q.zen ceiling system recall: inadequate X-ray tube cooling risk
FDA (Devices) · 2022-04-27
- HighBoston Scientific Recalls Auriga XL 4007 Laser Systems Due to Power Degradation
FDA (Devices) · 2019-05-29