Recall Z-2541-2018— Bio-Rad Laboratories Inc
Class II · Terminated
Class II FDA medical device recall by Bio-Rad Laboratories Inc, initiated 2018-04-02. FDA's recall record names no specific 510(k) clearance for this event. Product: PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid media. The instrument is intended to be used primarily for the in vitro diagnostic analysis of samples from the human body to obtain information oh physiological and pathological states.. Reason: The connector of the power supply was capable of fitting other components provided with the system. However, the voltage output of the reader power supply is incompatible with the other component and, if incorrectly connected, could result in irreparable damage to the system..
- Recalling firm
- Bio-Rad Laboratories Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-02
- Firm location
- Redmond, WA, United States
Product description
PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid media. The instrument is intended to be used primarily for the in vitro diagnostic analysis of samples from the human body to obtain information oh physiological and pathological states.
Reason for recall
The connector of the power supply was capable of fitting other components provided with the system. However, the voltage output of the reader power supply is incompatible with the other component and, if incorrectly connected, could result in irreparable damage to the system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.