Food, drugs, devices › Bio-Rad Laboratories Inc
Device recall: PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance
Bio-Rad Laboratories Inc (Redmond, WA) initiated this device recall on 2 Apr 2018; FDA lists 1 product record under event 80403, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated. Initiation: voluntary: firm initiated. Bio-Rad Laboratories Inc has 20 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bio-Rad Laboratories Inc, Redmond, WA.
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."
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2541-2018 | 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… | 153 | Class II | Terminated | 1 Aug 2018 |
Context
Other enforcement events for Bio-Rad Laboratories Inc
All 20 events for Bio-Rad Laboratories Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Terminated. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.