Medical Device Advisories

FDA Advisory No. 2017-248 || VOLUNTARY RECALL OF IPSOGEN BCR-ABL1 Mbcr IS-MMR Kit and IPSOGEN BCR-ABL1 Mbcr RGQ RT-PCR Kit

FDA Advisory No. 2017-248

VOLUNTARY RECALL OF IPSOGEN BCR-ABL1 Mbcr IS-MMR Kit and IPSOGEN BCR-ABL1 Mbcr RGQ RT-PCR Kit

All are hereby advised by the Food and Drug Administration (FDA) about the lots of the following Research Use Only (RUO) Ipsogen Kits distributed by Getz Bros. Philippines Inc. 5th floor Ortigas Bldg. Ortigas Ave Pasig City, Philippines:

Research Use Only (RUO) Kit name

Kit Ref

Kit Lot

IS-MMR Calibrator MAT

IS-MMR Calibrator LOT

Erroneous NCN Assigned IS-Cal Value for the IS-MMR Calibrator

Corrected NCN Assigned IS-Cal Value for the IS-MMR Calibrator

Ipsogen BCR-ABL1 MBCR IS-MMR Kit

670713

95701390

1071927

95701327

0.081

0.124

95701403

95701513

95701655

95701524

95700448

95700957

0.094

0.143

95700450

95700997

95701174

95701664

95701806

0.092

0.140

95701896

95701897

95701974

Ipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit

670913

95701191

1062899

95701222

0.1238

0.1848

95701413

95701532

95700425

95700842

0.1385

0.2057

The cited product are being voluntarily recalled by Getz Bros. Philippines Inc. because of the report issued by its main manufacturer in other country. According to the report, there is a labelling error in the IS-Cal Value used in the calculation for the conversion of the qualitative results to the international standard on certain lots. This error has led to significant change in the molecular response reporting for IS-MMR and RT-PCR kits. For the ipsogen BCR-ABL1 Mbcr IS-MMR kit, the magnitude of error may induce a change from “inconclusive result” to “MMR” status or “no MMR” status to “inconclusive result.” For ipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit the magnitude of error may induce a change from “MR4” to “MR4.5”; “MMR” to “MR4”; and “no MMR” to “MMR.” Thus, erroneous data might be obtained from these affected lots.

All consumers are advised not to purchase or use the affected product lots. Distributors, retailers, hospitals that have any lot of the stated medical device product are instructed to discontinue further distribution, sale and use.

Any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to FDA at telephone no. (02) 857-1900 loc. 8301 or email us at This email address is being protected from spambots. You need JavaScript enabled to view it..

Dissemination of the information to all concerned is requested.

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