Z-2546-2018Class II

Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium

Name: Z-2546-2018 Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium
Creator: Life Technologies, Corp.
Published: 2018-05-10
License: https://open.fda.gov/license/

Life Technologies Corporation / initiated 2018-05-10 / Terminated / root cause: packaging

FDA source

Life Technologies, Corp. began a recall of Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium on 2018-05-10. FDA classified it as Class II and gives the reason as "It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2546-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-10
Posted: 2018-07-25
Terminated: 2020-05-05
Recalling firm: Life Technologies Corporation
Product: Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium.
Product code: NDS Media, Culture, Ex Vivo, Tissue And Cell
Reason for recall: It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.
Root cause tag: packaging
FDA root cause: Unknown/Undetermined by firm
Action: Urgent Medical Device Recall Notification letters dated 6/28/18 were distributed to customers to notify them of the recall of GIBCO CTS AIM V Serum-Free Media (SFM); Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate; Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose; and Gibco RPMI 1640 Medium. The letters instructed customers to do the following: For the above mentioned lots of product, please complete an inspection of the seal integrity of your inventory. There should not be visual evidence of media within the space between the media bag itself and the dust cover. If you are using product that was manufactured between the dates noted above and you have confirmed media between the media bag and dust cover, we ask that you dispose of these bags per local and state requirements and complete the attached Customer Response Form. As noted above, for bags that do not have any visible media beyond the seal, we have confirmed through sterility testing that these units meet sterility specifications and are acceptable for use. Please inform all affected users within your organization of this notification. If you have used this product in manufacturing, you must notify impacted customers and impacted facilities of this notice and our concern for the potential of fill tube seal integrity loss. Please complete the following Customer Response Sheet if you have product that was manufactured between September 2017 and December 2017 and you have confirmed visual evidence of media between the media bag and dust cover. We will work with you to ensure that you receive credit for the discarded material. North American customers: Please complete the following Customer Response Sheet if you have confirmed visual evidence of at the bag-port or media between the media bag and dust cover in your material. Email a scanned copy of the response sheet along with this letter to [email protected]. If you have any questions, please ca
Quantity in commerce: 10
Distribution: Worldwide distribution. US states: CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, and WA., Canada, France, Great Britain, Japan, Korea, Netherlands, and Switzerland.
Product codes and lots: Lot: 1930752

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2546-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2542-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-25
Z-2543-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-25
Z-2544-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-25
Z-2545-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-25
Z-2546-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-25
Z-2547-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-25

Product code NDS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)