Recall Z-2541-2018 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Bio-Rad Laboratories Inc
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.
| Date | Apr 2, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | An Urgent Product Correction notification letter dated 4/2/18 was distributed to customers. The letter instructed customers to check the system and confirm it is labeled as shown in the letter. Then complete the attached form, indicating if the system includes a D-Link Brand USB hub, and fax or email back the form to Bio-Rad as soon as possible. If needed, a Bio-Rad Technical Support Representative will contact you shortly to arrange for replacement of the hub. |
| Quantity | 153 |
| Distribution | US Nationwide Distribution inn the states of : AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OR, PA, SC, TN, TX, VA, VT, WA, WI, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.