Device recall: Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049

FDA enforcement event 87010 · Class II · initiated 10 Dec 2020 · status Terminated · terminated 6 Jul 2023

DeviceVoluntary: Firm initiated1 product recordLenexa, KS

FDA enforcement event 87010 is a device recall by Remel Inc of Lenexa, KS, initiated 10 Dec 2020 and classified Class II, with 1 product record.

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. 93% of the 916 device enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 6 Jul 2023. Initiation: voluntary: firm initiated. Remel Inc has 50 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

Remel Inc, Lenexa, KS.

Reason for recall

"The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended."

Distribution

"Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0769-2021	Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049	637 units	Class II	Terminated	20 Jan 2021

Context

93%of 2020 device events are Class II916 events that year

1product record in this eventfirm median: 1

50events on this register for the firm

Other enforcement events for Remel Inc

Initiated	Product (first record)	Type	Class	Records
3 Jun 2026	GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460	Device	Class II	1
24 Mar 2026	Yeastone Broth, 11ML, 10/BOX YY3462	Device	Class II	1
5 Feb 2026	Campy CVA Medium 100/PK, R01272	Device	Class II	1
12 Nov 2025	1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450	Device	Class II	1
11 Jul 2025	Blood Agar,5% Sheep Blood 100/PK, Product Number R01202	Device	Class II	4
1 May 2025	Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; inv	Device	Class II	1
13 Feb 2025	remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use	Device	Class II	2
12 Feb 2025	Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Se	Device	Class II	1
20 Sep 2024	remel BactiDrop Acridine Orange, REF 21502, 50 per package.	Device	Class II	1
14 Aug 2023	remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containi	Device	Class II	1

All 50 events for Remel Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended."

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: "Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 6 Jul 2023. "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.